a. Field of Invention
The invention relates generally to drug delivery devices and methodologies for direct (needle) or indirect (e.g., intravernous) delivery of medication to a patient.
b. Description of Related Art
The following patents relate to the field of drug delivery devices:
U.S. Pat. No. 3,542,023 describes a two-compartment device for the administration of medicaments which is particularly adapted for containing a dry or lyophilized product and the diluent therefor in separate compartments until it is desired to administer the medicament whereupon the dry material and the liquid material may be readily mixed. The device includes a hypodermic syringe barrel having an open end and a closed end, a boss extending from said closed end, a needle affixed to the boss, means for enclosing medicament associated with the barrel, a tubular needle cover, one end of the needle cover sealing the boss, the other end containing an opening therein coaxial with said needle, received in said opening a medicament vial, said medicament vial having an open end and a closed end, received in the open end of said medicament vial a resilient imperforate stopper, said stopper being adapted to be punctured by the open end of said needle to permit the transfer of the contents of said medicament vial to the medicament container associated with said barrel and vice versa.
U.S. Pat. No. 3,980,083 to Elliott describes an infusor unit for dispensing a medicament by injection including a vial having an open end and a closed end and a resilient piston adapted to be initially partially inserted into said vial. The piston having a central through bore which is sealed by a transverse diaphragm and a chamber formed at one end of the piston by the diaphragm and a reduced entryway at its open end to define internal shoulder means. A substantially rigid hollow tubular infusor means which includes means for securing a sharpened cannula which extends outwardly from one end and in communication with the transparent interior of said infusor. The opposite end of the infusor having hollow means for sealing engagement with the piston bore for preassembly and, subsequently, to cooperatively penetrate said diaphragm to provide access of the hollow infusor and its connected passageway with the cannula to the interior of the piston sealed vial.
U.S. Pat. No. 4,592,745 describes a dispenser characterized by provision for use of a replaceable needle and a prefilled cartridge. The dispenser comprises an elongated body separable into two body sections, with the front end section adapted to contain a prefilled cartridge and with provision at the front end for mounting a needle removably thereon. The back end section contains the operating mechanism shown by FIG. 10 to convert the longitudinal movement of a pushable element into unidirectionally rotary movement, then into longitudinal movement of a piston rod that acts to expel fluid through the needle. A multipurpose cap is protective of the needle end when mounted on the front end, and is an operating member when mounted on the rear end, as is illustrated by FIGS. 1 and 2.
U.S. Pat. No. 4,861,335 to Reynolds describes a syringe which provides for the isolated storage of two components of a medicament until immediately prior to use of the syringe. One liquid component is stored in a collapsible chamber of a sealed capsule within a hollow plunger stem of the syringe, and the other component beneath the head of the plunger. A double headed needle arrangement between the head and stem of the plunger is caused to penetrate the plunger head and the capsule when the syringe is to be used so that the plunger may be drawn back to exhaust the contents of the capsule chamber into admixture with the component stored beneath the head of the plunger. Communication through the double headed needle arrangement is then interrupted before the plunger is used to eject the syringe contents through an external needle fitted to the syringe.
U.S. Pat. No. 4,886,495 to Reynolds describes a prefilled syringe for one or two component medicaments is based upon the use of a vial containing a medicament or one component of a medicament, the vial having an open bottom closed by a piston. When the piston is coupled with a plunger, and an adapter cap having an internal needle and an external connection for a needle is placed over a cap of the vial, the latter is converted into a prefilled syringe. The piston has an axial passage closed by a resealable septum, so that a separate diluent stored in a flexible capsule may be introduced into the vial through the piston by a double ended needle mounted on a further cap applied to the capsule, the further cap being coupled within the tubular interior of the plunger so that the double ended needle penetrates the septum in the piston. The capsule is pushed forward onto the double ended needle when its contents are to be expelled into the vial. The capsule and its cap are then removed and discarded.
U.S. Pat. No. 4,915,689 to Theeuwes describes a parenteral delivery system for delivering a beneficial agent. The delivery system comprises a reservoir containing a medical fluid, a vial containing a beneficial solid agent, and a manifold for establishing fluid communication between the reservoir and the vial.
U.S. Pat. No. 4,994,029 to Rohrbough describes a syringe mixer and injector device formed of an injector and an adaptor having opposed interconnectable nozzles, e.g. with mating luer lock connectors, on their facing ends and sockets in their remote ends. Each of the injector and adapter has a protected fluid pathway flow connecting its nozzle and socket, a guideway to receive at its remote end for movement thereon a medicament vial when the vial stopper is connected to its socket, and a recessed short tubular spike forming the pathway portion in its socket and protruding into the socket and terminating inwardly from its remote end sufficiently to protect the spike from unintended human contact and arranged to penetrate the stopper thereat to flow connect its vial with its pathway in protected condition. After charging the injector connected vial with the contents of the adapter connected vial, e.g. by one-way transfer thereto, the injector nozzle may be disconnected from the adapter nozzle and connected directly without modification to a dispensing device having a like nozzle to that of the adaptor. Each of the injector and adapter may be made of plastic as an integral one-piece member.
U.S. Pat. No. 5,069,670 to Vetter et al. describes a hypodermic syringe having a generally cylindrically tubular body extending along an axis and having an axial front end formed with a radially outwardly projecting annular bead, a piston axially displaceable in the body, a plug having a rearwardly directed flange fitting complementarily over the front end of the body at the bead and forwardly blocking the body, and a flat soft seal ring compressed axially between the plug and the front end of the body. The body has a rear end provided with a finger-rest crosspiece and the piston is provided with a plunger projecting axially out the rear end past the crosspiece.
U.S. Pat. No. 5,137,511 to Reynolds describes a prefilled syringe for one or two component medicaments is based upon the use of a vial containing a medicament or one component of a medicament, the vial having an open bottom closed by a piston. When a flexible extension of the piston is coupled with a tubular plunger, and an adaptor cap having an internal needle and an external connection for a needle is placed over a cap of the vial, the latter is converted into a prefilled syringe. The piston may have an axial passage closed by a resealable septum, so that a separate diluent stored in a flexible capsule may be introduced into the vial through the piston by a double ended needle mounted on a further cap applied to the capsule, the further cap being coupled within the tubular interior of the plunger so that the double ended needle penetrates the septum in the piston. The capsule is pushed forward onto the double ended needle when its contents are to expelled into the vial. The capsule and its cap are then removed and discarded. In an alternative arrangement, the cap of the capsule is coupled to the adaptor cap and the diluent introduced into the vial through a closure secured by the cap of the vial, after which the capsule is removed from the plunger and the latter is coupled to the piston.
U.S. Pat. No. 5,281,198 to Haber et al. describes a pharmaceutical component-mixing syringe assembly which is particularly suited for packaging, reconstituting and dispensing a series of equal doses of a multiple component pharmaceutical, such as human growth hormone reconstituted from a diluent component and a lyophilized component. The pharmaceutical components are contained within first and second cartridges of the type having a movable piston. The second cartridge is forced into the interior of the first cartridge causing a spike assembly between the two to fluidly couple the two cartridges and drive the piston of the first cartridge into the first cartridge causing the contents of the first cartridge to be driven into the second cartridge, thereby mixing. A reciprocating ratchet plunger is used to drive the second piston. The distance the ratchet plunger moves, and thus the dose, is determined by the position of a user-inaccessible dosing key stop along the length of the ratchet plunger.
U.S. Pat. No. 5,429,976 to Haber et al. describes a medication dispenser which is used to directly fill a syringe with measured amounts of one or more liquid medications, typically two different types of insulin, from containers, such as vials and cartridges each having a septum at one end; each cartridge has a pierceable piston at the other end. The septum of each container is pierced by hollow liquid spikes while hollow gas spikes pierce the septum of the vial and the piston of the cartridge. Liquid is pumped out of the container and air is replaced into the container through the liquid and gas spikes. Two of the cartridges can contain a diluent and a lyophilized component respectively; the diluent in the first cartridge can be pumped into the second cartridge through a one-way valve to create a mixed pharmaceutical which is then pumped into the syringe, with or without another pharmaceutical.
U.S. Pat. No. 5,466,220 to Brenneman describes a drug vial mixing and transfer device having a piercing connector or a syringe attached to the end of one or more ports with interconnecting fluid passageways. Further, the piercing connector is used to support and penetrate standard glass drug vials filled with powder or lyophilized drugs or liquid diluent, while the syringe is used to transfer liquid diluent and drug solutions between the vials and the syringe advantageously within a sealed system.
U.S. Pat. No. 5,478,316 describes a device for automatically injecting a material into the body. The device includes a drive assembly and a syringe assembly which is mounted to the drive assembly. The drive assembly includes a drive rod, a driver releasably coupled to the drive rod, and a constant force spring which urges the drive rod towards the syringe assembly. The spring first urges the coupled drive rod and driver along the axis of the device, causing the skin to be penetrated by the needle of the syringe assembly. The drive rod is then decoupled from the driver. The spring continues to urge the drive rod in the axial direction, whereby the drive rod engages a piston in the syringe assembly and causes the displacement of the material therein.
U.S. Pat. No. 5,554,125 to Reynolds describes a prefilled syringe for one or two component medicaments which is based upon the use of a vial containing a medicament or one component of a medicament, the vial having an open bottom closed by a piston. When a flexible extension of the piston is coupled with a tubular plunger, and an adaptor cap having an internal needle and an external connection for a needle is placed over a cap of the vial, the latter is converted into a prefilled syringe. The open bottom of the vial is configured so as not to interfere with handling of the vials by conventional vial sterilizing, filling and capping machinery, and may not be formed so as to provide an internal shoulder which will secure a piston retention member.
U.S. Pat. No. 5,673,094 describes a syringe for injecting multiple sequential dosages of a liquid medicine and includes a single actuator for initiating a penetration and injection sequence. The syringe hereof is adjustable for different dosages while providing for physical selection of a desired, predetermined dosage. The syringe includes a retraction mechanism for withdrawing the needle into a protective collar after administration of the dosage. The syringe receives a vial for administering multiple dosages without the necessity of replacing the vial after each administration.
U.S. Pat. No. 6,030,363 describes an injectable medicament dispenser for use in controllably dispensing fluid medicaments such as insulin, antibiotics, oncolytics and the like from a prefilled container at a uniform rate. The dispenser includes a unique stored energy source in the form of a compressively deformable, polymeric elastomeric member that provides the force necessary to controllably discharge the medicament from the prefilled container which is housed within the body of the device. After having been deformed, the polymeric, elastomeric member will return to its starting configuration in a highly predictable manner.
U.S. Pat. No. 6,221,041 B1 to Russo describes a fluid transfer device connecting a medical vessel and an intravenous bag for enabling the mixing in closed system of the two products contained therein by means of a syringe, comprising a three-way plug valve assembly with a first port ending in a connector for a syringe, and a second and a third port, each one provided into a respective spike connected to a housing for a container of medicinal product. Within the first one of the said two spikes a further independent channel is provided for the inlet and the outlet of air, communicating with the external environment through a hydrophobic filter. The second one of the said two spikes is capable of piercing the rubber closure of the injection point of a bag of medicinal product, and the corresponding housing consists of two flexible arms fastenable to each other at the respective ends, so as to be tightened around the tube of the said injection point.
U.S. Pat. No. 6,599,268 B1 describes a syringe that has a retractable needle and a barrel having an open proximal end and an open distal end defining a receiver with an inward shoulder. The barrel has a hollow bore, an elongate plunger with a proximal end and a distal open end with a cavity within. A stopper occludes the open end of the cavity. The syringe has an elongate hub with a proximal flange. The hub is within and sized for slideable movement within the receiver at the distal end of the barrel with the flange defining a distal end of a chamber. There is a sleeve sized to fit with a clearance about the hub disposed between the shoulder and the flange when the hub is in the receiver, the sleeve having a sharpened proximal end and a proximal end connected to the passageway of the hub with the pointed end of the needle extending outwardly. There is a spring disposed about the hub compressed to provide a bias between the receiver and the flange so that when a force greater than required to expel fluid from the chamber is applied, the plunger causes the cutting surface to cut through the flange and stopper and expose the cavity to allow the spring to urge the hub into the cavity in the plunger and retract the needle to a position within the syringe.
U.S. Pat. No. 6,632,198, B2 describes a retracting needle assembly for use with a syringe barrel having a cylindrical collar and a plunger having a release element with a sharp distal end includes an outer hub having a passageway therethrough and an inner hub having a proximal end, a distal end and a conduit therethrough. The proximal end of the inner hub has an inner portion and a dissociable outer portion connected to the inner portion. The dissociable outer portion is further connected to the outer hub. The distal end of the inner hub is smaller than the passageway of the outer hub at the distal end of the outer hub and projects distally outwardly therefrom. A needle channel having a distal end, a proximal end, and a lumen therethrough is connected to the inner hub so that the lumen is in fluid communication with the conduit. An energized spring is contained between the inner and outer hub. Structure is provided for connecting the outer hub to the collar of the syringe barrel.
U.S. Pat. No. 6,645,181 B1 describes a drug delivery device for mixing and delivering a drug by injection. The device includes a housing having a first port or opening therein that receives a first container that contains a fluid or powdered drug, for example a lyophilized drug. The housing can also include a second port or opening that receives a second container that contains a fluid to be mixed with the drug to form an injectable fluid. The device includes a manifold having a channel that fluidly connects the first and second containers. A penetration membrane such as a needle is used to inject the drug into a patient which is in fluid communication with the first container. The needle is moveable from a storage position in the housing to an injection position extending through the housing.
U.S. Pat. No. 6,652,483 B2 describes a device for providing medication for injection by a jet injector includes a cassette which connects an injector system to a reservoir. The cassette forms a fluid pathway at an interface of a cassette lower body and a cassette upper body. The cassette also forms an impulse chamber with a nozzle leading therefrom. The fluid pathway interconnects the reservoir with the impulse chamber. The medication flows from the reservoir along the fluid pathway and into the impulse chamber. Force from an impulse generator drives the fluid medicament from the impulse chamber through the nozzle, out an orifice in a tip of the nozzle, and into the skin of a patient. To prevent the pressure waves generated by the jet injector from breaking a glass cartridge in the reservoir, the fluid pathway is blocked, using a series of right angles or valves.
U.S. Pat. No. 6,669,671 B1 describes a retractable syringe needle comprising a needle assembly including: a needle-holding mechanism comprising a hub and an annular sleeve connected with said hub; a hypodermic needle extending through said hub; and a pin directly connected to the exterior surface of said annular sleeve; a container having a tubular wall with a longitudinal slot therein, said container having a first open end adapted to receive a syringe barrel and a second open end adapted to admit a syringe needle, said container having said needle assembly mounted therein so that the pin is slideably engaged by the longitudinal slot, so that said needle assembly may be moved from a first position where the needle is within the container to a second position where the needle is exposed by sliding the pin toward the second open end of the container and causing the needle to pass though the second open end; a means for biasing the needle assembly toward said first position; and means for releasably engaging the pin at a defined location in said longitudinal slot so as to hold said needle assembly in said second position; wherein said means for releasably engaging the pin comprises a notch which intersects said longitudinal slot at said defined location, so that said needle assembly may be releasably held in said second position by sliding said pin out of said longitudinal slot into said notch.
U.S. Pat. No. 6,676,641 B2 describes a hypodermic syringe that includes a barrel with a plunger assembly slideably extending therein. The plunger assembly includes an outer plunger and an inner plunger telescoping together with a bungee in tension. A seal stop is located at the seal end of the plunger assembly and holds an annular seal in radial extension sealing against the internal sidewall of the barrel. A luer hub assembly is fixed at the needle end of the barrel. A plunger cap may be advanced after injection to rotate the plunger assembly. Such rotation engages a probe on the end of the plunger assembly with the luer hub, disengages the seal stop to release the annular seal, engages the seal stop with the luer plunger assembly causing release of the luer hub assembly from the barrel and releases the engagement between the outer plunger and inner plunger. The foregoing provides for the retraction of the luer hub and associated needle into the barrel.
U.S. Pat. No. 6,685,677 B2 describes a needle assembly withdraws medicine from a vial having a rubber septum and injects the medicine into a port in a patient while not endangering the caregiver with an accidental stick with a contaminated used needle. The needle assembly includes a sharp hollow needle for penetrating a septum of a vial and a blunt cannula for injecting into an injection port. The needle can be of any type including intramuscular. The blunt cannula concentrically surrounding the sharp hollow needle, and extends relative to the sharp hollow needle in a locked position.
U.S. Pat. No. 6,706,031 B2 describes a needleless access system adapted to be mounted on a vial comprising a generally elongated tubular housing having an interior dividing wall, flexible hooks projecting upwardly from the dividing wall which are diametrically opposed, a pair of confronting splines projecting upwardly from the interior dividing wall, a hub insert having a piercing tip normally supported in an armed position by hook elements, a series of outwardly projecting teeth which engage and are guided in the splines during axial displacement of the hub insert relative to the splined housing, and said hub insert having means for mounting a syringe assembly whereby the hub insert maybe activated axially guided by the splines so that the piercing tip engages the stopper in a vial aligned therewith.
U.S. Pat. No. 6,752,782 B2 describes an automatically retractable safety syringe includes a needle assembly consisting of a cannula, a needle hub and a rubber O-ring, a needle cap, a retracting spring, a breakable and retractable plunger, a plunger gasket and a medicine barrel; in accordance with the structure of the said automatically retractable safety syringe of the present invention, since the breakable plunger is assembled inside the medicine barrel, after being pushed all the way to the end, it is forced to break automatically into two parts for reducing its length so as to provide enough space for the retracting spring to drive the needle assembly moving along the sliding passages for accomplishing an automatically retracting action.
U.S. Pat. No. 6,776,775 B1 describes a retractable needle assembly for use in medical procedures, comprising a needle assembly including a hub, a hollow needle passing though the hub and projecting from the posterior end of the hub, and a tubular sleeve having a radially directed hole therethrough connected with the anterior end of the hub; a tubular sheath having a wall with a radially directed hole therethrough, wherein the needle assembly is positioned within the tubular sheath so that it may be moved reversibly between an exposed position and a retracted position; a means for reversibly locking the needle assembly in its exposed position; a means for reversibly locking the needle assembly in its retracted position; and a means for permanently locking the needle assembly in its retracted position, said permanent locking means comprising a radially-directed peg mounted on an exterior surface of the tubular sheath so that one end of the radially-directed peg is adapted to be pushed inwardly through the hole in the wall of the tubular sheath and through the hole in the tubular sleeve, wherein said one end of the radially-directed peg may not be withdrawn through the hole in the tubular sleeve after it has been pushed through the hole in the tubular sleeve.
U.S. Pat. No. 6,800,067 B2 describes a safety syringe that includes two major components; a barrel and a plunger; a needle hub engaged with the barrel and a plunger slid ably received in the barrel to engage with the needle hub and to retract the needle into the barrel. A V-shaped groove formed a thin membrane surround the needle hub. The V-shape groove separates the needle hub and the barrel into two peripheries-an inner periphery of the barrel and an outer periphery of the hub. The inner periphery of the barrel and the outer periphery of the hub are thicker then the thin membrane. Multiple pyramidal blocks extended from the outer periphery of the hub facing outward to the barrel. Multiple triangular cutouts with V-shape groove edge defined in the inner periphery of the barrel respectively correspond to one of the multiple pyramidal blocks.
U.S. Pat. No. 6,846,301 B2 describes a safety syringe includes a generally tubular body having a needle end and plunger end, needle and retractable needle seat, two-way valve, plunger, stopper, piston, and rear plunger may be moved to create a vacuum in the plunger. The user then moves the plunger toward the needle end, pressurizing a vial, then pulls backward to a selected position corresponding to the desired volume of fluid to be withdrawn. At the conclusion of the injection stroke, the piston is disengaged from the plunger. The vacuum within the plunger retracts the needle safely into the tubular body.
U.S. Pat. No. 6,805,689 B2 describes a blood collector system utilizes a standard disposable needle assembly and standard blood collecting and receiving tubes of the type sealed by a pierceable septum. The system has a hollow cylinder, including an internally apertured sleeve into which the needle assembly is mounted and into which the sealed blood collecting tubes are inserted to be pierced by a needle of the needle assembly. A protective sheath with two clips is concentrically mounted to the barrel cylinder with slot on both sides of the barrel so that the hollow cylinder can move down to cover the patent contacted needle. On both sides of the barrel, there are one upper slot and one lower slot, a slot channel between the upper slot and lower slot. The clip is shaped so that it can snap in the upper and lower slot and can be only slide down from the upper slot to lower slot, but not backwards. After the needle is taken out from a patient, the clip will be pushed down out of the upper slot, then slide down through the slot channel, then be pushed down to snap in the low slot of the barrel in order to cover the used needle from a patient. The apparatus of the invention eliminates the health care worker's exposure to accidental needle pricks.
U.S. Pat. No. 6,863,659 B2 describes a sharp safe hydraulic retractable syringe that is supplied with a hypodermic needle fully housed within an elongated hollow barrel which cannot be used until the plunger rod stop has been removed and the plunger rod has been pushed into the loading position to receive the required liquid into the elongated hollow barrel. The hydraulic retractable syringe assembly is preceded by a retractable mechanism is contained by a three-legged retaining clip to hold twin conical helical shape springs separated by a spring separation plate within two spring retaining cups. Twin conical shape springs are released by the hydraulic pressure exerted by the liquid onto the activating ring with three molded pistons which passes through a sealing member and exerts axial pressure onto the three release sides to introduce radial pressure onto the three-legged clip to release the conical spring pressure placed onto two spring retaining cups causing the twin conical helical shape springs to be set apart and retract up into the elongated hollow barrel. The three-legged retaining clip has two of its three legs preset so as to force the spring separating plate against the hypodermic needle causing the hypodermic needle to misalign and thereby rendering the sharp safe hydraulic retractable syringe non-functional for reuse. This invention can be incorporated into any syringe.
U.S. Pat. No. 6,872,190 B1 describes a syringe that comprises a body forming a liquid reservoir, carrying a needle for injecting the liquid, and having a plunger movably mounted in the body. The body is housed in a safety sheath to be axially movable between an active position in which the needle projects through a distal end of the sheath and a protection position in which the needle is retracted inside the sheath and towards which position the body is urged resiliently. The body is prevented from moving relative to the sheath in the active position by locking means that opposite the resilient force on the body, and that are releasable by means which are activated when the plunger is in an end-of-liquid-injection position.
U.S. Pat. No. 6,926,696 B2 describes a retractable needle assembly for use in medical procedures comprising a needle assembly including a hub, a hollow needle passing through the hub and projecting from the posterior end of the hub. A tubular sheath having a longitudinal slot extending along a portion of its length. A post attached to the hub and positioned to project through said longitudinal slot such that the needle and hub assembly may slide along the length of the sheath from a position exposing said needle to a retracted position, a means for reversibly locking the needle in the exposed position and means for permanently locking the needle in the retracted position both reversibly or permanently are disclosed. Ivan
U.S. Pat. No. 7,025,389 B2 describes a method and device for facilitating fluid communication between a sealed container having an access port and at least one fluid passageway. The device includes a connector provided with a body that defines a fluid passageway between first and second ends of the body. The first end of the body is configured for receiving the fluid source, and the second end is configured for receiving an access port of the container. A locking member is associated with the body and prevents movement of the body relative to the access port with the locking member is in a locked position. The device scan be used for the transfer of cytotoxic or other drugs (i.e., fluids) to the container and may remain attached to the access port and used to administer a drug from the container to a patient by means of an administration set with a male luer connector.
Notwithstanding the foregoing prior art patents, the present invention is neither taught nor rendered obvious in view of said prior art references.